Safety Evaluation of β-arbutin in Healthy Human Subjects

The objective and purpose of this Phase I study is to investigate the safety of synthetic beta-arbutin, administered to healthy human subjects for: i) 12 weeks, at a dose of 150 mg/day, and ii) 4 weeks, at a dose of 400mg/day. Safety will be determined by assessing adverse event rates between treatment groups and mean changes relative to baseline in serum biochemical, hematological and urinary markers.

Inclusion criteria

• Adults, aged 18-65 years
• includes non-pregnant, non-breastfeeding women on adequate birth control
• acceptable effective contraceptive methods for participants with child-bearing potential include: barrier methods (condoms), total abstinence, hormonal birth control methods (oral, injectable, transdermal, or intra-vaginal), intrauterine devices, and confirmed successful vasectomy of partner;
• Body Mass Index (BMI) of 18.5-35 kg/m2;
• Generally healthy (absence of active clinical disease as determined by serum biochemical, hematological, and urinary parameter tests as well as detailed medical history and blood pressure measurements) as assessed by the PI/QI;
• Males and females of childbearing potential willing to use appropriate effective contraception for the duration of the study;
• Agrees to maintain current diet and exercise routine during the study;
• Ability to provide written informed consent; and
• Willing to comply with all study requirements and provide urine and blood specimens over the 12-week study period..

Exclusion criteria

• Pregnant or breastfeeding women;
• History of renal dysfunction;
• History of macular degeneration as assessed by the PI/QI;
• History of liver disease as assessed by the PI/QI;
• Type I or Type II diabetes;
• Unstable hypertension. Treatment on a stable dose of medication for at least 3 months will be considered by the PI/QI History of renal dysfunction, as assessed by the PI/QI;
• Cancer being actively treated with systemic therapy (i.e. chemotherapy, immune therapy);
• Self-reported HIV-, Hepatitis B-, and/or C-positive diagnosis;
• High alcohol intake (average of > 2 standard drinks per day);
• Heavy smokers (average of >10 cigarettes per day);
• Use of cannabinoid products within 30 days of enrollment;
• Any history of major surgery (i.e. inter-abdominal, inter-thoracic, inter-cranial) within the last six months, or surgery planned during the course of the study;
• Known hypersensitivity to arbutin;
• Allergy to all ingredients (including non-medicinal ingredients) in investigational products and placebo product
• Self-reported medical or neuropsychological condition and/or cognitive impairment that, in the QI's opinion, could interfere with study participation; and
• Clinically significant abnormal laboratory results at screening as assessed by the PI/QI